Stability Indicating Method for Determination of Sodium Picosulfate in Pharmaceutical Preparation - Comparison of HPLC, UHPLC and HTLC

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11160%2F17%3A10364425" target="_blank" >RIV/00216208:11160/17:10364425 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.eurekaselect.com/142317/article" target="_blank" >http://www.eurekaselect.com/142317/article</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2174/1573412912666160518145632" target="_blank" >10.2174/1573412912666160518145632</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Stability Indicating Method for Determination of Sodium Picosulfate in Pharmaceutical Preparation - Comparison of HPLC, UHPLC and HTLC

Popis výsledku v původním jazyce

Background: Various chromatographic modes were used for the evaluation of liquid pharmaceutical preparation containing favorite laxative drug sodium picosulfate. Objective: The aim of this study was to compare capabilities of conventional HPLC, UHPLC and HTLC on the example of stability indicating methods with UV 263 nm detection for simultaneous determination of sodium picosulfate, its two degradation products and sodium benzoate in oral liquid pharmaceutical preparation. Method: A novel money-saving preparation of system suitability test solution using partial acid hydrolysis yielding main degradation products was developed. Developed HPLC system with RP-C18e column used acetonitrile - propan-2-ol - phosphate puffer pH 7.0 with addition of cetyltrimethylammonium bromide (43: 2: 55, v/v/v) as mobile phase, 1 ml/min, column temperature 40 degrees C. UHPLC separation was carried out using core-shell RP-C18 column under the same chromatographic conditions, flow-rate 0.5 ml/min. HTLC method used the same column as in UHPLC, mobile phase acetonitrile -30 mM triethylamine phosphate buffer pH 5.0 (10: 90, v/v), flow-rate 0.5 ml/min and column temperature 100 degrees C. Results: HPLC method was very reliable and robust but rather time consuming, whereas UHPLC brought 5times faster analysis with 10times lower solvent consumption. High temperature during HTLC separation did not affect the stability of the tested compounds, and organic solvents consumption was 8times lower. Conclusion: Although all developed methods were satisfactorily validated, UHPLC is the most suitable technique for routine analysis or stability studies.

Název v anglickém jazyce

Stability Indicating Method for Determination of Sodium Picosulfate in Pharmaceutical Preparation - Comparison of HPLC, UHPLC and HTLC

Popis výsledku anglicky

Background: Various chromatographic modes were used for the evaluation of liquid pharmaceutical preparation containing favorite laxative drug sodium picosulfate. Objective: The aim of this study was to compare capabilities of conventional HPLC, UHPLC and HTLC on the example of stability indicating methods with UV 263 nm detection for simultaneous determination of sodium picosulfate, its two degradation products and sodium benzoate in oral liquid pharmaceutical preparation. Method: A novel money-saving preparation of system suitability test solution using partial acid hydrolysis yielding main degradation products was developed. Developed HPLC system with RP-C18e column used acetonitrile - propan-2-ol - phosphate puffer pH 7.0 with addition of cetyltrimethylammonium bromide (43: 2: 55, v/v/v) as mobile phase, 1 ml/min, column temperature 40 degrees C. UHPLC separation was carried out using core-shell RP-C18 column under the same chromatographic conditions, flow-rate 0.5 ml/min. HTLC method used the same column as in UHPLC, mobile phase acetonitrile -30 mM triethylamine phosphate buffer pH 5.0 (10: 90, v/v), flow-rate 0.5 ml/min and column temperature 100 degrees C. Results: HPLC method was very reliable and robust but rather time consuming, whereas UHPLC brought 5times faster analysis with 10times lower solvent consumption. High temperature during HTLC separation did not affect the stability of the tested compounds, and organic solvents consumption was 8times lower. Conclusion: Although all developed methods were satisfactorily validated, UHPLC is the most suitable technique for routine analysis or stability studies.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Current Pharmaceutical Analysis

ISSN

1573-4129

e-ISSN

—

Svazek periodika

13

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

AE - Spojené arabské emiráty

Počet stran výsledku

6

Strana od-do

250-255

Kód UT WoS článku

000402460300007

EID výsledku v databázi Scopus

2-s2.0-85019749394